Effects of Acute Red Raspberry Consumption on Vascular Function in Healthy Individuals

NCT02734901 | Completed

• 2 other identifiers: Rapsberry15-038
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Accumulating evidence from epidemiological and human intervention studies indicates that the cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related to their (poly)phenol content. Raspberries are rich in phenolic and polyphenolic compounds, in particular procyanidins, ellagitannins and anthocyanins, but also phenolic acids. At present, a small number of randomized controlled trials investigating the effects of berry (poly)phenols on validated surrogate markers of cardiovascular disease risk have shown promising results. However, to date, very few human studies have specifically investigated the effects of raspberry (poly)phenols on cardiovascular function in healthy subjects. Moreover, ellagitannin-derived metabolites are believed to persist for a long period of time in the blood and urine. Therefore, the investigators will investigate the presence of plasma and urinary raspberry-derived metabolites 24h post-consumption. To the investigators knowledge, the effects of red raspberry consumption on vascular function in humans have not been investigated before. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of raspberries,. Therefore, this study aims to investigate the potential role of red raspberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma.

Conditions

Healthy

Keywords

polyphenols; vascular function; endothelial function; raspberry

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 2 hour and 24 hour in Endothelial function

  measured by flow mediated dilation (FMD) on baseline at 2 and 24 hour postconsumption

  Baseline, 2 hour and 24 hour

Secondary Outcomes (4)

• Change from baseline to 2 hour and 24 hour in Pulse wave velocity

  Baseline, 2 hour and 24 hour

• Change from baseline to 2 hour and 24 hour in Central blood pressure

  Baseline, 2 hour and 24 hour

• Peripheral blood pressure

  Baseline, 2 h and 24 h

• Change from baseline to 2 hour and 24 hour in Heart rate

  Baseline, 2 hour and 24 hour

Other Outcomes (2)

• Change from baseline to 2 hour and 24 hour in Polyphenol metabolites in blood plasma

  Baseline, 2 hour and 24 hour

• Change from baseline to 2 hour and 24 hour in Polyphenol metabolites in urine

  Baseline, 2 hour and 24 hour

Study Arms (3)

400 g frozen raspberries

ACTIVE COMPARATOR

Red raspberry beverage Acute intake of 600 mL (1x daily)

Dietary Supplement: 400 g frozen raspberries

200 g frozen raspberries

ACTIVE COMPARATOR

Red raspberry beverage Acute intake of 600 mL (1x daily)

Dietary Supplement: 200 g frozen raspberries

Placebo control

PLACEBO COMPARATOR

Raspberry deprived supplement Acute intake of 600 mL (1x daily)

Dietary Supplement: Placebo

Interventions

400 g frozen raspberries DIETARY_SUPPLEMENT

1x daily intake of 600 mL red raspberry beverage

400 g frozen raspberries

200 g frozen raspberries DIETARY_SUPPLEMENT

1x daily intake of 600 mL red raspberry beverage

200 g frozen raspberries

Placebo DIETARY_SUPPLEMENT

1x daily intake of 600 mL raspberry deprived supplement

Placebo control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male subjects (no clinical signs or symptoms of cardiovascular disease)

You may not qualify if:

• Cardiovascular disease
• acute inflammation
• cardiac arrhythmia
• renal failure
• heart failure (NYHA II-IV)
• diabetes mellitus
• C - reactive protein \> 05 mg/dL
• malignant disease
• raspberry allergy/intolerance
• hypotension (≤100 / 60 mm Hg)

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location

Related Publications (1)

• Istas G, Feliciano RP, Weber T, Garcia-Villalba R, Tomas-Barberan F, Heiss C, Rodriguez-Mateos A. Plasma urolithin metabolites correlate with improvements in endothelial function after red raspberry consumption: A double-blind randomized controlled trial. Arch Biochem Biophys. 2018 Aug 1;651:43-51. doi: 10.1016/j.abb.2018.05.016. Epub 2018 May 24.

  PMID: 29802820 DERIVED

Study Officials

• Ana Rodriguez-Mateos, PhD

  Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

  PRINCIPAL INVESTIGATOR

• Christian Heiss, MD

  Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: April 12, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 20, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)